MAUDE Adverse Event Report: CONCENTRIC MEDICAL 9F BGC 95CM; CATHETER PERCUTANEOUS

Catalog Number 90074

Device Problem Material Rupture (1546)

Patient Problem No Patient Involvement (2645)

Event Date 11/08/2015

Event Type  malfunction  

Manufacturer Narrative

Event date: the exact date of the adverse event is unknown.The subject device was disposed of at the hospital.

Event Description

It was reported that during preparation, the subject device ruptured.No patient involved during the event.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore analysis of the device cannot be performed.From the information that was reported, the user may have over inflated the balloon during preparation as a 20cc syringe was used to inflate the balloon.Per the directions for use (dfu), "to inflate balloon, transfer maximum recommended balloon inflation volume from 20 ml syringe to 1 ml syringe and gently infuse balloon inflation media with 1 ml syringe until desired balloon diameter is attained." using a 20cc syringe can cause the balloon to rupture by allowing more than the maximum recommended inflation media into the balloon; therefore, the investigation concluded that the assignable cause was related to the dfu instructions not followed.

Event Description

It was reported that during preparation, the subject device ruptured.No patient involved during the event.

• Brand Name: 9F BGC 95CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): CONCENTRIC MEDICAL; 301 east evelyn; mountain view CA 94041
• Manufacturer (Section G): CONCENTRIC MEDICAL; 301 east evelyn; mountain view CA 94041
• Manufacturer Contact: sanda dracic ; 301 east evelyn; mountain view, CA 94041 ; 6509382100
• MDR Report Key: 5303641
• MDR Text Key: 34446865
• Report Number: 0002954917-2015-00133
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 90074
• Device Lot Number: 39017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2015
• Initial Date FDA Received: 12/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1